FDA Inspection
Scholten Surgical InstrumentsScholten Surgical Instruments – FDA Inspection, Jan 21, 2010
Record Details
This FDA Inspection record concerns Scholten Surgical Instruments, with an inspection on January 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 21, 2010
- Product Type
- Devices
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ID · e1b04825-3e5b-42ef-a434-9da9213cbef2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642925
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
- 21 CFR 820.100(b)Procedures
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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Other FDA inspections of Scholten Surgical Instruments
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Scholten Surgical Instruments
- FDA Inspection 904917 - 2014-12-05
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